MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® CARDIOFORM SEPTAL OCCLUDER; OCCLUDER, TRANSCATHETER SEPTAL

Catalog Number GSX0030A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Stroke/CVA (1770)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).

Event Description

It was reported a 30mm gore cardioform septal occluder was implanted on (b)(6) 2017 to close a patent foramen ovale.In (b)(6) 2017, the patient presented with a stroke and follow-up imaging showed two septal shunts.One shunt was behind the aorta and the second shunt was posterior and inferior to the occluder.The second shunt appeared to be a new or previously undetected septal defect.On (b)(6) 2017, a transcatheter reintervention was performed and a 25mm cribriform device was implanted in each shunt with no reported adverse effects to the patient.

Manufacturer Narrative

Results: case imaging was received for evaluation.Prior to defect closure, transesophageal echocardiographic images show a multifenestrated defect with an aneurysmal septum.Intracardiac echocardiographic images from the initial procedure ((b)(6) 2017) show no shunts across the implanted gore cardioform septal occluder on color flow doppler, and the occluder is shown splaying around the retro aortic root.Intracardiac echocardiographic images from (b)(6) 2017 show the gore cardioform septal occluder capturing the superior and inferior septal rims; however, a large shunt is seen in the anterior superior portion of the septum.The reported posterior inferior shunt cannot be confirmed by color flow doppler but depictions of a cribriform device on the posterior inferior aspects of the gore cardioform septal occluder confirm an additional defect in that position.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: OCCLUDER, TRANSCATHETER SEPTAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6852898
• MDR Text Key: 85443517
• Report Number: 2017233-2017-00459
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2019
• Device Catalogue Number: GSX0030A
• Device Lot Number: 15869525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 86